Trials / Completed
CompletedNCT05763082
Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis
Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Padagis' Roflumilast Cream 0.3% to Arcutis's Zoryve™ (Roflumilast Cream 0.3%) Cream and Both Active Treatments to a Vehicle Control in the Treatment of Plaque Psoriasis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 414 (actual)
- Sponsor
- Padagis LLC · Industry
- Sex
- All
- Age
- 12 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
To compare the safety and efficacy of Padagis' product to an FDA approved product for the treatment of plaque psoriasis
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | roflumilast cream 0.3% | test product |
| DRUG | Zoryve | Reference Listed Drug product |
| DRUG | Placebo | placebo |
Timeline
- Start date
- 2023-02-07
- Primary completion
- 2023-08-08
- Completion
- 2023-08-08
- First posted
- 2023-03-10
- Last updated
- 2024-08-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05763082. Inclusion in this directory is not an endorsement.